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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03932734
Other study ID # Survey Jawaug v1.0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 30, 2019
Est. completion date January 31, 2020

Study information

Verified date July 2019
Source Universitair Ziekenhuis Brussel
Contact Veerle Van Mossevelde, SC
Phone +3224763134
Email veerle.vanmossevelde@uzbrussel.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The survey studies patient satisfaction after titanium patient specific jawline augmentation in congenital, post-trauma, deformity and transgender/cosmetic jaw angle/border deficiencies.


Description:

Additively manufactured titanium implants have been pre-designed in the hospital department, further designed and manufactured by 2 Belgian companies. The issue is if all patients have satisfactory perception of the improvement of their morphology and the actual outcome of the procedure, and how theur social ineractions are perceived today.


Recruitment information / eligibility

Status Recruiting
Enrollment 26
Est. completion date January 31, 2020
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- All lower jaw augmentation implants

Exclusion Criteria:

- N/A

Study Design


Intervention

Other:
survey
Face-Q conversion table

Locations

Country Name City State
Belgium Universitair Ziekenhuis Brussel Jette Vlaams Brabant

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Satisfaction/Quality of Life By means of 4 surveys (social, psychological, outcome and satisfaction) based on FACE-Q. The scales can be used independently of the other scales.Higher scores reflect a better outcome. If missing data is less than 50% of the scale's items, insert the mean of the completed items. Use the Conversion Table to convert the raw summed scale score into a score from 0 (worst) to 100 (best). 1 year
See also
  Status Clinical Trial Phase
Terminated NCT02175576 - Randomized Controlled Clinical Outcomes of the Vanguard XP Bicruciate Knee System N/A